12 Results found
05/06/2024
Do your methods comply with the new ICH requirements?
ICH Q2(R2) and ICH Q14 describe mandatory requirements for the development, life cycle and validation of analytical methods.
08/22/2023
Prohibition of PFAS – Evaluate, assess risks, time to act
Valicare experts present solutions to you Per- und Polyfluoroalkyl substances (PFAS) are widely used in the pharmaceutical and biotech industry as ...
08/02/2023
Revision of Annex 1 - New approaches are required soon!
Get an overview about the most important upcoming changes The revision of Annex 1 of the EU GMP Guideline will be effective this year. It faces ...
04/13/2023
SMEPAC Test to Measure the Tightness of Containment Systems
Working with highly active and hazardous drugs and ingredients requires evidence that the used containment systems are leak proof!
08/29/2022
Computerized System Validation (CSV) – GAMP 5 Second Edition
2nd Edition of the GAMP 5 Guideline will address required changes in computerized system validation (CSV). Have you adopted the changes yet?
06/25/2022
New ICH Q14 Guideline: Analytical procedure development
Analytical procedure development: harmonization, development process as well as improvement of change management, approval and communication with ...
02/18/2022
Revision of ICH Q9 (R1) Guideline on Quality Risk Management
Innovations in the implementation of risk management in the pharmaceutical industry: product availability, hazard identification, and attention to ...
04/15/2021
Toxicological assessment gain acceptance for cleaning validation
WHO publishes decision on setting acceptance criteria for cleaning validation
01/08/2021
Integrated Qualification and Validation Guide
New ECA guide helps saving time and money by customer-supplier partnership on qualification and validation.
10/26/2020
Nitrosamines in active substances and finished medicinal products
EMA strongly requests the risk-based proof that active substances and finished medicinal products are free of nitrosamines. Are you prepared for this?
06/15/2020
Cleanroom standard series ISO 14644
The globally recognized standard for the classification of cleanrooms is "ISO 14644 – cleanrooms and associated cleanroom areas". In addition to the ...
06/12/2020
Pharmaceutical procurement & supplier qualification
Through Pharmaceutical Procurement and Supplier Qualification the quality of the components and the compliance to GMP is ensured.